Key clinical point: The prophylactic use of etoricoxib reduced the incidence and severity of taxane-associated acute pain syndrome (T-APS) and potentially attenuated docetaxel-induced peripheral neuropathy in patients receiving docetaxel-based chemotherapy for breast cancer (BC).

Major finding: Incidence rates of all T-APS (57.1% vs 91.5%) and severe T-APS (11.4% vs 54.9%; both P < .001) were significantly lower in the etoricoxib vs no treatment group. At 3 months follow-up after 4 cycles of docetaxel chemotherapy, the etoricoxib vs no treatment group showed a significantly higher mean Functional Assessment of Cancer Treatment Neurotoxicity subscale score (38.46 vs 34.59; P < .001).

Study details: Findings are from a phase 2 study including 144 adult women with stage I-III BC who received 4 cycles of docetaxel-based chemotherapy and were randomly assigned to receive prophylactic etoricoxib or no treatment.

Disclosures: This study was supported by grants from the National Natural Science Foundation of China and other sources. The authors declared no conflicts of interest.

Source: Zhang J et al. Prevention of taxane-associated acute pain syndrome with etoricoxib for patients with breast cancer: A phase II randomised trial. Eur J Cancer. 2022;171:150-160 (Jun 17). Doi: 10.1016/j.ejca.2022.05.019

Key clinical point: The prophylactic use of etoricoxib reduced the incidence and severity of taxane-associated acute pain syndrome (T-APS) and potentially attenuated docetaxel-induced peripheral neuropathy in patients receiving docetaxel-based chemotherapy for breast cancer (BC).

Major finding: Incidence rates of all T-APS (57.1% vs 91.5%) and severe T-APS (11.4% vs 54.9%; both P < .001) were significantly lower in the etoricoxib vs no treatment group. At 3 months follow-up after 4 cycles of docetaxel chemotherapy, the etoricoxib vs no treatment group showed a significantly higher mean Functional Assessment of Cancer Treatment Neurotoxicity subscale score (38.46 vs 34.59; P < .001).

Study details: Findings are from a phase 2 study including 144 adult women with stage I-III BC who received 4 cycles of docetaxel-based chemotherapy and were randomly assigned to receive prophylactic etoricoxib or no treatment.

Disclosures: This study was supported by grants from the National Natural Science Foundation of China and other sources. The authors declared no conflicts of interest.

Source: Zhang J et al. Prevention of taxane-associated acute pain syndrome with etoricoxib for patients with breast cancer: A phase II randomised trial. Eur J Cancer. 2022;171:150-160 (Jun 17). Doi: 10.1016/j.ejca.2022.05.019

Key clinical point: The prophylactic use of etoricoxib reduced the incidence and severity of taxane-associated acute pain syndrome (T-APS) and potentially attenuated docetaxel-induced peripheral neuropathy in patients receiving docetaxel-based chemotherapy for breast cancer (BC).

Major finding: Incidence rates of all T-APS (57.1% vs 91.5%) and severe T-APS (11.4% vs 54.9%; both P < .001) were significantly lower in the etoricoxib vs no treatment group. At 3 months follow-up after 4 cycles of docetaxel chemotherapy, the etoricoxib vs no treatment group showed a significantly higher mean Functional Assessment of Cancer Treatment Neurotoxicity subscale score (38.46 vs 34.59; P < .001).

Study details: Findings are from a phase 2 study including 144 adult women with stage I-III BC who received 4 cycles of docetaxel-based chemotherapy and were randomly assigned to receive prophylactic etoricoxib or no treatment.

Disclosures: This study was supported by grants from the National Natural Science Foundation of China and other sources. The authors declared no conflicts of interest.

Source: Zhang J et al. Prevention of taxane-associated acute pain syndrome with etoricoxib for patients with breast cancer: A phase II randomised trial. Eur J Cancer. 2022;171:150-160 (Jun 17). Doi: 10.1016/j.ejca.2022.05.019

Key clinical point: First-line treatment with nivolumab, bevacizumab, and paclitaxel showed promising efficacy with a tolerable safety profile in patients with human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (BC).

Major finding: The objective response rate was 70% (95% CI 55.9%-81.2%) in the overall cohort of patients with HER2-negative metastatic BC, 74% in patients with hormone receptor-positive BC, and 59% in patients with triple-negative BC. Grade 3/4 adverse drug reactions were reported by 58% of patients.

Study details: Findings are primary results from the phase 2 NEWBEAT study including 57 women with invasive, metastatic, or inoperable HER2-negative BC who received the first-line triple therapy with nivolumab, bevacizumab, and paclitaxel.

Disclosures: This study was supported by Ono Pharmaceutical Company. The authors declared receiving research funds, grants, personal fees, lecture fees, honoraria, or consulting fees from several sources, including Ono Pharmaceuticals.

Source: Ozaki Y et al. Safety and efficacy of nivolumab plus bevacizumab, paclitaxel for HER2-negative metastatic breast cancer: Primary results and biomarker data from a phase 2 trial (WJOG9917B). Eur J Cancer. 2022;171:193-202 (Jun 18). Doi: 10.1016/j.ejca.2022.05.014

Key clinical point: First-line treatment with nivolumab, bevacizumab, and paclitaxel showed promising efficacy with a tolerable safety profile in patients with human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (BC).

Major finding: The objective response rate was 70% (95% CI 55.9%-81.2%) in the overall cohort of patients with HER2-negative metastatic BC, 74% in patients with hormone receptor-positive BC, and 59% in patients with triple-negative BC. Grade 3/4 adverse drug reactions were reported by 58% of patients.

Study details: Findings are primary results from the phase 2 NEWBEAT study including 57 women with invasive, metastatic, or inoperable HER2-negative BC who received the first-line triple therapy with nivolumab, bevacizumab, and paclitaxel.

Disclosures: This study was supported by Ono Pharmaceutical Company. The authors declared receiving research funds, grants, personal fees, lecture fees, honoraria, or consulting fees from several sources, including Ono Pharmaceuticals.

Source: Ozaki Y et al. Safety and efficacy of nivolumab plus bevacizumab, paclitaxel for HER2-negative metastatic breast cancer: Primary results and biomarker data from a phase 2 trial (WJOG9917B). Eur J Cancer. 2022;171:193-202 (Jun 18). Doi: 10.1016/j.ejca.2022.05.014

Key clinical point: First-line treatment with nivolumab, bevacizumab, and paclitaxel showed promising efficacy with a tolerable safety profile in patients with human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (BC).

Major finding: The objective response rate was 70% (95% CI 55.9%-81.2%) in the overall cohort of patients with HER2-negative metastatic BC, 74% in patients with hormone receptor-positive BC, and 59% in patients with triple-negative BC. Grade 3/4 adverse drug reactions were reported by 58% of patients.

Study details: Findings are primary results from the phase 2 NEWBEAT study including 57 women with invasive, metastatic, or inoperable HER2-negative BC who received the first-line triple therapy with nivolumab, bevacizumab, and paclitaxel.

Disclosures: This study was supported by Ono Pharmaceutical Company. The authors declared receiving research funds, grants, personal fees, lecture fees, honoraria, or consulting fees from several sources, including Ono Pharmaceuticals.

Source: Ozaki Y et al. Safety and efficacy of nivolumab plus bevacizumab, paclitaxel for HER2-negative metastatic breast cancer: Primary results and biomarker data from a phase 2 trial (WJOG9917B). Eur J Cancer. 2022;171:193-202 (Jun 18). Doi: 10.1016/j.ejca.2022.05.014

Key clinical point: The risk for hemorrhage was not significantly different in patients with breast cancer (BC) aged ≥ 66 years who received direct oral anticoagulants (DOAC) concurrently with tamoxifen vs aromatase inhibitors (AI).

Major finding: During a median follow-up of 166 days, the risk for major hemorrhage requiring an emergency department visit or hospitalization (2.5% vs 3.3%; weighted hazard ratio [HR] 0.68; 95% CI 0.44-1.06) or any hemorrhage (4.9% vs 4.6%; weighted HR 1.04; 95% CI 0.75-1.43) was not higher with tamoxifen+DOAC compared with AI+DOAC.

Study details: Findings are from a population-based, retrospective cohort study including 4753 patients aged ≥ 66 years with BC who were prescribed tamoxifen or AI concurrently with a DOAC.

Disclosures: This study was supported by Canadian Institutes of Health Research and ICES. Some authors declared serving on advisory boards of or receiving grants, personal fees, or travel expenses from several sources.

Source: Wang T-F et al. Hemorrhage risk among patients with breast cancer receiving concurrent direct oral anticoagulants with tamoxifen vs aromatase inhibitors. JAMA Netw Open. 2022;5(6):e2219128 (Jun 28). Doi: 10.1001/jamanetworkopen.2022.19128

Key clinical point: The risk for hemorrhage was not significantly different in patients with breast cancer (BC) aged ≥ 66 years who received direct oral anticoagulants (DOAC) concurrently with tamoxifen vs aromatase inhibitors (AI).

Major finding: During a median follow-up of 166 days, the risk for major hemorrhage requiring an emergency department visit or hospitalization (2.5% vs 3.3%; weighted hazard ratio [HR] 0.68; 95% CI 0.44-1.06) or any hemorrhage (4.9% vs 4.6%; weighted HR 1.04; 95% CI 0.75-1.43) was not higher with tamoxifen+DOAC compared with AI+DOAC.

Study details: Findings are from a population-based, retrospective cohort study including 4753 patients aged ≥ 66 years with BC who were prescribed tamoxifen or AI concurrently with a DOAC.

Disclosures: This study was supported by Canadian Institutes of Health Research and ICES. Some authors declared serving on advisory boards of or receiving grants, personal fees, or travel expenses from several sources.

Source: Wang T-F et al. Hemorrhage risk among patients with breast cancer receiving concurrent direct oral anticoagulants with tamoxifen vs aromatase inhibitors. JAMA Netw Open. 2022;5(6):e2219128 (Jun 28). Doi: 10.1001/jamanetworkopen.2022.19128

Key clinical point: The risk for hemorrhage was not significantly different in patients with breast cancer (BC) aged ≥ 66 years who received direct oral anticoagulants (DOAC) concurrently with tamoxifen vs aromatase inhibitors (AI).

Major finding: During a median follow-up of 166 days, the risk for major hemorrhage requiring an emergency department visit or hospitalization (2.5% vs 3.3%; weighted hazard ratio [HR] 0.68; 95% CI 0.44-1.06) or any hemorrhage (4.9% vs 4.6%; weighted HR 1.04; 95% CI 0.75-1.43) was not higher with tamoxifen+DOAC compared with AI+DOAC.

Study details: Findings are from a population-based, retrospective cohort study including 4753 patients aged ≥ 66 years with BC who were prescribed tamoxifen or AI concurrently with a DOAC.

Disclosures: This study was supported by Canadian Institutes of Health Research and ICES. Some authors declared serving on advisory boards of or receiving grants, personal fees, or travel expenses from several sources.

Source: Wang T-F et al. Hemorrhage risk among patients with breast cancer receiving concurrent direct oral anticoagulants with tamoxifen vs aromatase inhibitors. JAMA Netw Open. 2022;5(6):e2219128 (Jun 28). Doi: 10.1001/jamanetworkopen.2022.19128

Key clinical point: Digital breast tomosynthesis (DBT) reduced the likelihood of advanced breast cancer (BC) diagnosis compared with digital mammography in women with extremely dense breasts and a high risk for BC.

Major finding: Overall screening outcomes per 1000 examinations were similar with DBT vs digital mammography for interval invasive cancer (difference −0.04; 95% CI −0.14 to 0.06); however, the advanced cancer detection rate was lower in women with extremely dense breasts and a high BC risk (difference −0.53; 95% CI −0.97 to −0.10).

Study details: Findings are from a cohort study including 504,427 women with no history of BC or mastectomy who underwent 1,003,900 digital mammography screening examinations or 374,002 DBT screening examinations.

Disclosures: This study was funded by Patient-Centered Outcomes Research Institute, National Cancer Institute, and other sources. Some authors declared receiving grants, consulting fees, or royalties from or serving as consultants or on the editorial board for several sources.

Source: Kerlikowske K et al. Association of screening with digital breast tomosynthesis vs digital mammography with risk of interval invasive and advanced breast cancer. JAMA. 2022;327(22):2220–2230 (Jun 14). Doi: 10.1001/jama.2022.7672

Key clinical point: Digital breast tomosynthesis (DBT) reduced the likelihood of advanced breast cancer (BC) diagnosis compared with digital mammography in women with extremely dense breasts and a high risk for BC.

Major finding: Overall screening outcomes per 1000 examinations were similar with DBT vs digital mammography for interval invasive cancer (difference −0.04; 95% CI −0.14 to 0.06); however, the advanced cancer detection rate was lower in women with extremely dense breasts and a high BC risk (difference −0.53; 95% CI −0.97 to −0.10).

Study details: Findings are from a cohort study including 504,427 women with no history of BC or mastectomy who underwent 1,003,900 digital mammography screening examinations or 374,002 DBT screening examinations.

Disclosures: This study was funded by Patient-Centered Outcomes Research Institute, National Cancer Institute, and other sources. Some authors declared receiving grants, consulting fees, or royalties from or serving as consultants or on the editorial board for several sources.

Source: Kerlikowske K et al. Association of screening with digital breast tomosynthesis vs digital mammography with risk of interval invasive and advanced breast cancer. JAMA. 2022;327(22):2220–2230 (Jun 14). Doi: 10.1001/jama.2022.7672

Key clinical point: Digital breast tomosynthesis (DBT) reduced the likelihood of advanced breast cancer (BC) diagnosis compared with digital mammography in women with extremely dense breasts and a high risk for BC.

Major finding: Overall screening outcomes per 1000 examinations were similar with DBT vs digital mammography for interval invasive cancer (difference −0.04; 95% CI −0.14 to 0.06); however, the advanced cancer detection rate was lower in women with extremely dense breasts and a high BC risk (difference −0.53; 95% CI −0.97 to −0.10).

Study details: Findings are from a cohort study including 504,427 women with no history of BC or mastectomy who underwent 1,003,900 digital mammography screening examinations or 374,002 DBT screening examinations.

Disclosures: This study was funded by Patient-Centered Outcomes Research Institute, National Cancer Institute, and other sources. Some authors declared receiving grants, consulting fees, or royalties from or serving as consultants or on the editorial board for several sources.

Source: Kerlikowske K et al. Association of screening with digital breast tomosynthesis vs digital mammography with risk of interval invasive and advanced breast cancer. JAMA. 2022;327(22):2220–2230 (Jun 14). Doi: 10.1001/jama.2022.7672

Key clinical point: Trastuzumab deruxtecan vs physician’s choice of chemotherapy reduced the risk for disease progression or death by ~50% in previously treated patients with human epidermal growth factor receptor-2 (HER2)-low metastatic breast cancer (BC).

Major finding: Trastuzumab deruxtecan vs chemotherapy significantly improved the median progression-free survival in the overall cohort of patients (hazard ratio for disease progression/death [HR] 0.50; P < .001), irrespective of the hormone-receptor status (positive: HR 0.51; P < .001, or negative: HR 0.46; 95% CI 0.24-0.89). The incidence of grade ≥3 adverse events was 52.6% with trastuzumab deruxtecan and 67.4% with chemotherapy.

Study details: Findings are from the phase 3 DESTINY-Breast04 study including 557 patients with HER2-low metastatic BC who were previously treated with 1 or 2 lines of chemotherapy and were randomly assigned to receive trastuzumab deruxtecan or physician’s choice of chemotherapy.

Disclosures: This study was supported by Daiichi Sankyo and AstraZeneca. Four authors declared being employees or stockholders of Daiichi Sankyo, and the other authors reported ties with various sources, including AstraZeneca and Daiichi Sankyo.

Source: Modi S et al. Trastuzumab deruxtecan in previously treated HER2-low advanced breast cancer. N Engl J Med. 2022;387:9-20 (Jun 5). Doi: 10.1056/NEJMoa2203690

Key clinical point: Trastuzumab deruxtecan vs physician’s choice of chemotherapy reduced the risk for disease progression or death by ~50% in previously treated patients with human epidermal growth factor receptor-2 (HER2)-low metastatic breast cancer (BC).

Major finding: Trastuzumab deruxtecan vs chemotherapy significantly improved the median progression-free survival in the overall cohort of patients (hazard ratio for disease progression/death [HR] 0.50; P < .001), irrespective of the hormone-receptor status (positive: HR 0.51; P < .001, or negative: HR 0.46; 95% CI 0.24-0.89). The incidence of grade ≥3 adverse events was 52.6% with trastuzumab deruxtecan and 67.4% with chemotherapy.

Study details: Findings are from the phase 3 DESTINY-Breast04 study including 557 patients with HER2-low metastatic BC who were previously treated with 1 or 2 lines of chemotherapy and were randomly assigned to receive trastuzumab deruxtecan or physician’s choice of chemotherapy.

Disclosures: This study was supported by Daiichi Sankyo and AstraZeneca. Four authors declared being employees or stockholders of Daiichi Sankyo, and the other authors reported ties with various sources, including AstraZeneca and Daiichi Sankyo.

Source: Modi S et al. Trastuzumab deruxtecan in previously treated HER2-low advanced breast cancer. N Engl J Med. 2022;387:9-20 (Jun 5). Doi: 10.1056/NEJMoa2203690

Key clinical point: Trastuzumab deruxtecan vs physician’s choice of chemotherapy reduced the risk for disease progression or death by ~50% in previously treated patients with human epidermal growth factor receptor-2 (HER2)-low metastatic breast cancer (BC).

Major finding: Trastuzumab deruxtecan vs chemotherapy significantly improved the median progression-free survival in the overall cohort of patients (hazard ratio for disease progression/death [HR] 0.50; P < .001), irrespective of the hormone-receptor status (positive: HR 0.51; P < .001, or negative: HR 0.46; 95% CI 0.24-0.89). The incidence of grade ≥3 adverse events was 52.6% with trastuzumab deruxtecan and 67.4% with chemotherapy.

Study details: Findings are from the phase 3 DESTINY-Breast04 study including 557 patients with HER2-low metastatic BC who were previously treated with 1 or 2 lines of chemotherapy and were randomly assigned to receive trastuzumab deruxtecan or physician’s choice of chemotherapy.

Disclosures: This study was supported by Daiichi Sankyo and AstraZeneca. Four authors declared being employees or stockholders of Daiichi Sankyo, and the other authors reported ties with various sources, including AstraZeneca and Daiichi Sankyo.

Source: Modi S et al. Trastuzumab deruxtecan in previously treated HER2-low advanced breast cancer. N Engl J Med. 2022;387:9-20 (Jun 5). Doi: 10.1056/NEJMoa2203690

Scientists seeking to stay ahead of an evolving SARS-Cov-2 virus are looking at new strategies, including developing intranasal vaccines, according to speakers at a conference on July 26.

The Biden administration held a summit on the future of COVID-19 vaccines, inviting researchers to provide a public update on efforts to try to keep ahead of SARS-CoV-2.

Scientists and federal officials are looking to build on the successes seen in developing the original crop of COVID vaccines, which were authorized for use in the United States less than a year after the pandemic took hold.

But emerging variants are eroding these gains. For months now, officials at the Centers for Disease Control and Prevention and Food and Drug Administration have been keeping an eye on how the level of effectiveness of COVID vaccines has waned during the rise of the Omicron strain. And there’s continual concern about how SARS-CoV-2 might evolve over time.

“Our vaccines are terrific,” Ashish K. Jha, MD, the White House’s COVID-19 response coordinator, said at the summit. “[But] we have to do better.”

Among the approaches being considered are vaccines that would be applied intranasally, with the idea that this might be able to boost the immune response to SARS-CoV-2.

At the summit, Akiko Iwasaki, PhD, of Yale University, New Haven, Conn., said the intranasal approach might be helpful in preventing transmission as well as reducing the burden of illness for those who are infected with SARS-CoV-2.

“We’re stopping the virus from spreading right at the border,” Dr. Iwasaki said at the summit. “This is akin to putting a guard outside of the house in order to patrol for invaders compared to putting the guards in the hallway of the building in the hope that they capture the invader.”

Dr. Iwasaki is one of the founders of Xanadu Bio, a private company created last year to focus on ways to kill SARS-CoV-2 in the nasosinus before it spreads deeper into the respiratory tract. In an editorial in Science Immunology, Dr. Iwasaki and Eric J. Topol, MD, director of the Scripps Research Translational Institute, urged greater federal investment in this approach to fighting SARS-CoV-2. (Dr. Topol is editor-in-chief of Medscape.)

Titled “Operation Nasal Vaccine – Lightning speed to counter COVID-19,” their editorial noted the “unprecedented success” seen in the rapid development of the first two mRNA shots. Dr. Iwasaki and Dr. Topol noted that these victories had been “fueled by the $10 billion governmental investment in Operation Warp Speed.

“During the first year of the pandemic, meaningful evolution of the virus was slow-paced, without any functional consequences, but since that time we have seen a succession of important variants of concern, with increasing transmissibility and immune evasion, culminating in the Omicron lineages,”  wrote Dr. Iwasaki and Dr. Topol.

Recent developments have “spotlighted the possibility of nasal vaccines, with their allure for achieving mucosal immunity, complementing, and likely bolstering the circulating immunity achieved via intramuscular shots,” they added.
 

An early setback

Scientists at the National Institutes of Health and the Biomedical Advanced Research and Development Authority (BARDA) have for some time been looking to vet an array of next-generation vaccine concepts, including ones that trigger mucosal immunity, the Washington Post reported in April.

At the summit on July 26, several participants, including Dr. Jha, stressed the role that public-private partnerships were key to the rapid development of the initial COVID vaccines. They said continued U.S. government support will be needed to make advances in this field.

One of the presenters, Biao He, PhD, founder and president of CyanVac and Blue Lake Biotechnology, spoke of the federal support that his efforts have received over the years to develop intranasal vaccines. His Georgia-based firm already has an experimental intranasal vaccine candidate, CVXGA1-001, in phase 1 testing (NCT04954287).

The CVXGA-001 builds on technology already used in a veterinary product, an intranasal vaccine long used to prevent kennel cough in dogs, he said at the summit.

The emerging field of experimental intranasal COVID vaccines already has had at least one setback.

The biotech firm Altimmune in June 2021 announced that it would discontinue development of its experimental intranasal AdCOVID vaccine following disappointing phase 1 results. The vaccine appeared to be well tolerated in the test, but the immunogenicity data demonstrated lower than expected results in healthy volunteers, especially in light of the responses seen to already cleared vaccines, Altimmune said in a release. 

In the statement, Scot Roberts, PhD, chief scientific officer at Altimmune, noted that the study participants lacked immunity from prior infection or vaccination. “We believe that prior immunity in humans may be important for a robust immune response to intranasal dosing with AdCOVID,” he said.

At the summit, Marty Moore, PhD, cofounder and chief scientific officer for Redwood City, Calif.–based Meissa Vaccines, noted the challenges that remain ahead for intranasal COVID vaccines, while also highlighting what he sees as the potential of this approach.

Meissa also has advanced an experimental intranasal COVID vaccine as far as phase 1 testing (NCT04798001).

“No one here today can tell you that mucosal COVID vaccines work. We’re not there yet. We need clinical efficacy data to answer that question,” Dr. Moore said.

But there’s a potential for a “knockout blow to COVID, a transmission-blocking vaccine” from the intranasal approach, he said.

“The virus is mutating faster than our ability to manage vaccines and not enough people are getting boosters. These injectable vaccines do a great job of preventing severe disease, but they do little to prevent infection” from spreading, Dr. Moore said.

A version of this article first appeared on Medscape.com.

Scientists seeking to stay ahead of an evolving SARS-Cov-2 virus are looking at new strategies, including developing intranasal vaccines, according to speakers at a conference on July 26.

The Biden administration held a summit on the future of COVID-19 vaccines, inviting researchers to provide a public update on efforts to try to keep ahead of SARS-CoV-2.

Scientists and federal officials are looking to build on the successes seen in developing the original crop of COVID vaccines, which were authorized for use in the United States less than a year after the pandemic took hold.

But emerging variants are eroding these gains. For months now, officials at the Centers for Disease Control and Prevention and Food and Drug Administration have been keeping an eye on how the level of effectiveness of COVID vaccines has waned during the rise of the Omicron strain. And there’s continual concern about how SARS-CoV-2 might evolve over time.

“Our vaccines are terrific,” Ashish K. Jha, MD, the White House’s COVID-19 response coordinator, said at the summit. “[But] we have to do better.”

Among the approaches being considered are vaccines that would be applied intranasally, with the idea that this might be able to boost the immune response to SARS-CoV-2.

At the summit, Akiko Iwasaki, PhD, of Yale University, New Haven, Conn., said the intranasal approach might be helpful in preventing transmission as well as reducing the burden of illness for those who are infected with SARS-CoV-2.

“We’re stopping the virus from spreading right at the border,” Dr. Iwasaki said at the summit. “This is akin to putting a guard outside of the house in order to patrol for invaders compared to putting the guards in the hallway of the building in the hope that they capture the invader.”

Dr. Iwasaki is one of the founders of Xanadu Bio, a private company created last year to focus on ways to kill SARS-CoV-2 in the nasosinus before it spreads deeper into the respiratory tract. In an editorial in Science Immunology, Dr. Iwasaki and Eric J. Topol, MD, director of the Scripps Research Translational Institute, urged greater federal investment in this approach to fighting SARS-CoV-2. (Dr. Topol is editor-in-chief of Medscape.)

Titled “Operation Nasal Vaccine – Lightning speed to counter COVID-19,” their editorial noted the “unprecedented success” seen in the rapid development of the first two mRNA shots. Dr. Iwasaki and Dr. Topol noted that these victories had been “fueled by the $10 billion governmental investment in Operation Warp Speed.

“During the first year of the pandemic, meaningful evolution of the virus was slow-paced, without any functional consequences, but since that time we have seen a succession of important variants of concern, with increasing transmissibility and immune evasion, culminating in the Omicron lineages,”  wrote Dr. Iwasaki and Dr. Topol.

Recent developments have “spotlighted the possibility of nasal vaccines, with their allure for achieving mucosal immunity, complementing, and likely bolstering the circulating immunity achieved via intramuscular shots,” they added.
 

An early setback

Scientists at the National Institutes of Health and the Biomedical Advanced Research and Development Authority (BARDA) have for some time been looking to vet an array of next-generation vaccine concepts, including ones that trigger mucosal immunity, the Washington Post reported in April.

At the summit on July 26, several participants, including Dr. Jha, stressed the role that public-private partnerships were key to the rapid development of the initial COVID vaccines. They said continued U.S. government support will be needed to make advances in this field.

One of the presenters, Biao He, PhD, founder and president of CyanVac and Blue Lake Biotechnology, spoke of the federal support that his efforts have received over the years to develop intranasal vaccines. His Georgia-based firm already has an experimental intranasal vaccine candidate, CVXGA1-001, in phase 1 testing (NCT04954287).

The CVXGA-001 builds on technology already used in a veterinary product, an intranasal vaccine long used to prevent kennel cough in dogs, he said at the summit.

The emerging field of experimental intranasal COVID vaccines already has had at least one setback.

The biotech firm Altimmune in June 2021 announced that it would discontinue development of its experimental intranasal AdCOVID vaccine following disappointing phase 1 results. The vaccine appeared to be well tolerated in the test, but the immunogenicity data demonstrated lower than expected results in healthy volunteers, especially in light of the responses seen to already cleared vaccines, Altimmune said in a release. 

In the statement, Scot Roberts, PhD, chief scientific officer at Altimmune, noted that the study participants lacked immunity from prior infection or vaccination. “We believe that prior immunity in humans may be important for a robust immune response to intranasal dosing with AdCOVID,” he said.

At the summit, Marty Moore, PhD, cofounder and chief scientific officer for Redwood City, Calif.–based Meissa Vaccines, noted the challenges that remain ahead for intranasal COVID vaccines, while also highlighting what he sees as the potential of this approach.

Meissa also has advanced an experimental intranasal COVID vaccine as far as phase 1 testing (NCT04798001).

“No one here today can tell you that mucosal COVID vaccines work. We’re not there yet. We need clinical efficacy data to answer that question,” Dr. Moore said.

But there’s a potential for a “knockout blow to COVID, a transmission-blocking vaccine” from the intranasal approach, he said.

“The virus is mutating faster than our ability to manage vaccines and not enough people are getting boosters. These injectable vaccines do a great job of preventing severe disease, but they do little to prevent infection” from spreading, Dr. Moore said.

A version of this article first appeared on Medscape.com.

Scientists seeking to stay ahead of an evolving SARS-Cov-2 virus are looking at new strategies, including developing intranasal vaccines, according to speakers at a conference on July 26.

The Biden administration held a summit on the future of COVID-19 vaccines, inviting researchers to provide a public update on efforts to try to keep ahead of SARS-CoV-2.

Scientists and federal officials are looking to build on the successes seen in developing the original crop of COVID vaccines, which were authorized for use in the United States less than a year after the pandemic took hold.

But emerging variants are eroding these gains. For months now, officials at the Centers for Disease Control and Prevention and Food and Drug Administration have been keeping an eye on how the level of effectiveness of COVID vaccines has waned during the rise of the Omicron strain. And there’s continual concern about how SARS-CoV-2 might evolve over time.

“Our vaccines are terrific,” Ashish K. Jha, MD, the White House’s COVID-19 response coordinator, said at the summit. “[But] we have to do better.”

Among the approaches being considered are vaccines that would be applied intranasally, with the idea that this might be able to boost the immune response to SARS-CoV-2.

At the summit, Akiko Iwasaki, PhD, of Yale University, New Haven, Conn., said the intranasal approach might be helpful in preventing transmission as well as reducing the burden of illness for those who are infected with SARS-CoV-2.

“We’re stopping the virus from spreading right at the border,” Dr. Iwasaki said at the summit. “This is akin to putting a guard outside of the house in order to patrol for invaders compared to putting the guards in the hallway of the building in the hope that they capture the invader.”

Dr. Iwasaki is one of the founders of Xanadu Bio, a private company created last year to focus on ways to kill SARS-CoV-2 in the nasosinus before it spreads deeper into the respiratory tract. In an editorial in Science Immunology, Dr. Iwasaki and Eric J. Topol, MD, director of the Scripps Research Translational Institute, urged greater federal investment in this approach to fighting SARS-CoV-2. (Dr. Topol is editor-in-chief of Medscape.)

Titled “Operation Nasal Vaccine – Lightning speed to counter COVID-19,” their editorial noted the “unprecedented success” seen in the rapid development of the first two mRNA shots. Dr. Iwasaki and Dr. Topol noted that these victories had been “fueled by the $10 billion governmental investment in Operation Warp Speed.

“During the first year of the pandemic, meaningful evolution of the virus was slow-paced, without any functional consequences, but since that time we have seen a succession of important variants of concern, with increasing transmissibility and immune evasion, culminating in the Omicron lineages,”  wrote Dr. Iwasaki and Dr. Topol.

Recent developments have “spotlighted the possibility of nasal vaccines, with their allure for achieving mucosal immunity, complementing, and likely bolstering the circulating immunity achieved via intramuscular shots,” they added.
 

An early setback

Scientists at the National Institutes of Health and the Biomedical Advanced Research and Development Authority (BARDA) have for some time been looking to vet an array of next-generation vaccine concepts, including ones that trigger mucosal immunity, the Washington Post reported in April.

At the summit on July 26, several participants, including Dr. Jha, stressed the role that public-private partnerships were key to the rapid development of the initial COVID vaccines. They said continued U.S. government support will be needed to make advances in this field.

One of the presenters, Biao He, PhD, founder and president of CyanVac and Blue Lake Biotechnology, spoke of the federal support that his efforts have received over the years to develop intranasal vaccines. His Georgia-based firm already has an experimental intranasal vaccine candidate, CVXGA1-001, in phase 1 testing (NCT04954287).

The CVXGA-001 builds on technology already used in a veterinary product, an intranasal vaccine long used to prevent kennel cough in dogs, he said at the summit.

The emerging field of experimental intranasal COVID vaccines already has had at least one setback.

The biotech firm Altimmune in June 2021 announced that it would discontinue development of its experimental intranasal AdCOVID vaccine following disappointing phase 1 results. The vaccine appeared to be well tolerated in the test, but the immunogenicity data demonstrated lower than expected results in healthy volunteers, especially in light of the responses seen to already cleared vaccines, Altimmune said in a release. 

In the statement, Scot Roberts, PhD, chief scientific officer at Altimmune, noted that the study participants lacked immunity from prior infection or vaccination. “We believe that prior immunity in humans may be important for a robust immune response to intranasal dosing with AdCOVID,” he said.

At the summit, Marty Moore, PhD, cofounder and chief scientific officer for Redwood City, Calif.–based Meissa Vaccines, noted the challenges that remain ahead for intranasal COVID vaccines, while also highlighting what he sees as the potential of this approach.

Meissa also has advanced an experimental intranasal COVID vaccine as far as phase 1 testing (NCT04798001).

“No one here today can tell you that mucosal COVID vaccines work. We’re not there yet. We need clinical efficacy data to answer that question,” Dr. Moore said.

But there’s a potential for a “knockout blow to COVID, a transmission-blocking vaccine” from the intranasal approach, he said.

“The virus is mutating faster than our ability to manage vaccines and not enough people are getting boosters. These injectable vaccines do a great job of preventing severe disease, but they do little to prevent infection” from spreading, Dr. Moore said.

A version of this article first appeared on Medscape.com.

Drinks sweetened with sugar – but not natural juices or drinks sweetened artificially – were linked to a higher risk of inflammatory bowel disease (IBD) in people who drank more than one a day in a study of more than 120,000 people.

IBD has previously been linked with high consumption of sugar, but population-based evidence has been inconclusive, and natural juices have not been studied, write lead author Tian Fu, with the department of gastroenterology, the Third Xiangya Hospital of Central South University in Changsha, China, and colleagues.

Their study compared the associations of sugar-sweetened drinks, artificially sweetened beverages, and natural juices (including pure fruit or vegetable juices) with IBD risk.

“As one of the major sources of free sugar, beverages have been related to inflammation-related health outcomes but received less attention in the field of IBD,” the authors wrote.

“Our findings, if proven causal, suggest reduced consumption of sugar-sweetened beverages as a strategy for prevention of IBD, especially Crohn’s disease (CD), but further studies are needed to confirm these findings and explore the underlying mechanism,” they write.

The study was published online in Alimentary Pharmacology and Therapeutics.
 

Link significant for Crohn’s disease but not ulcerative colitis

The researchers used data from 121,490 participants in the UK Biobank who did not have IBD at trial recruitment in 2006-2010. The average age of the participants was 56 years, and almost all (96.9%) were White. The researchers studied their intake of beverages with 24-hour diet recalls from 2009 to 2012.

Participants were sorted into three groups according to the consumption of each beverage: 0 unit (glasses, cans, or 250 mL/cartons) per day (reference group), 0-1 unit per day, and more than 1 unit per day.

While most (66.3%) did not drink any sugar-sweetened beverages, participants who reported drinking more than 1 unit per day were more likely to have a higher body mass index and consume higher amounts of total energy and sugar.

During an average follow-up of about 10 years, the investigators documented 510 incident IBD cases: 143 cases of CD and 367 cases of ulcerative colitis (UC).

Compared to people who did not drink sugar-sweetened beverages, those who drank at least 1 unit per day had a significantly higher IBD risk (hazard ratio, 1.51; 95% confidence interval, 1.11-2.05), but the trend was statistically nonsignificant.

The association was significant for CD (HR, 2.05; 95% CI, 1.22,3.46) but not for UC (HR, 1.31; 95% CI, 0.89-1.92). The positive association between sugar-sweetened drinks and risk of CD, but not UC, was in line with previous studies showing that dietary patterns were more associated with CD risk, the authors noted.

They also highlighted that there was no positive link between artificially sweetened beverages, natural juices, or total sugar intake and IBD risk. They noted that the inflammatory role of artificial sweeteners is still being debated.

Additionally, the effect of natural sugar in juices may be counteracted by fiber and bioactive compounds in the juices, the authors wrote.

A limitation of the study is that at baseline, all participants in the UK Biobank were older than 40 years, so the researchers could not examine any links with younger-onset IBD.

Additionally, the self-reported questionnaires are subject to recall bias, though the survey has been validated.
 

Study adds to previous evidence

Hasan Zaki, PhD, an assistant professor with the department of pathology at University of Texas Southwestern Medical Center, Dallas, said in an interview that the size of this population-based study adds evidence that simple sugar can increase the risk for IBD. Dr. Zaki studies the relationship of inflammatory disorders and diet and was not involved in the study.

“This study is very strong evidence of the association between high sugar and IBD,” he said. He noted that more studies are needed because there are few studies in this area and results have varied.

His lab conducted work on the subject previously in mice. In a 2020 study, they found that a high-sugar diet helped promote IBD development and gut microbiota dysfunction.

Dr. Zaki pointed out that, among people in the United Kingdom and those in the United States, diets, demographics, and IBD incidence are similar, a fact that may make the findings more generalizable.

However, studies comparing the categories of sweetened drinks should be conducted in a U.S. population to assess the results in a diverse group to see whether ethnicity plays a role, because almost all of the people in the UK group were White, he said.

Also important, Dr. Zaki said, will be follow-up studies of the link between sweet drinks and IBD in U.S. children, among whom consumption is particularly high and the IBD incidence is rising. One study showed the prevalence increased 133% from 2007 to 2016.

The results of this study should help gastroenterologists counsel patients on an ideal diet to avoid IBD or reduce IBD severity, he said.

The study was supported by the National Natural Science Foundation of China and Key Project of Research and Development Plan of Hunan Province. The study authors and Dr. Zaki report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Drinks sweetened with sugar – but not natural juices or drinks sweetened artificially – were linked to a higher risk of inflammatory bowel disease (IBD) in people who drank more than one a day in a study of more than 120,000 people.

IBD has previously been linked with high consumption of sugar, but population-based evidence has been inconclusive, and natural juices have not been studied, write lead author Tian Fu, with the department of gastroenterology, the Third Xiangya Hospital of Central South University in Changsha, China, and colleagues.

Their study compared the associations of sugar-sweetened drinks, artificially sweetened beverages, and natural juices (including pure fruit or vegetable juices) with IBD risk.

“As one of the major sources of free sugar, beverages have been related to inflammation-related health outcomes but received less attention in the field of IBD,” the authors wrote.

“Our findings, if proven causal, suggest reduced consumption of sugar-sweetened beverages as a strategy for prevention of IBD, especially Crohn’s disease (CD), but further studies are needed to confirm these findings and explore the underlying mechanism,” they write.

The study was published online in Alimentary Pharmacology and Therapeutics.
 

Link significant for Crohn’s disease but not ulcerative colitis

The researchers used data from 121,490 participants in the UK Biobank who did not have IBD at trial recruitment in 2006-2010. The average age of the participants was 56 years, and almost all (96.9%) were White. The researchers studied their intake of beverages with 24-hour diet recalls from 2009 to 2012.

Participants were sorted into three groups according to the consumption of each beverage: 0 unit (glasses, cans, or 250 mL/cartons) per day (reference group), 0-1 unit per day, and more than 1 unit per day.

While most (66.3%) did not drink any sugar-sweetened beverages, participants who reported drinking more than 1 unit per day were more likely to have a higher body mass index and consume higher amounts of total energy and sugar.

During an average follow-up of about 10 years, the investigators documented 510 incident IBD cases: 143 cases of CD and 367 cases of ulcerative colitis (UC).

Compared to people who did not drink sugar-sweetened beverages, those who drank at least 1 unit per day had a significantly higher IBD risk (hazard ratio, 1.51; 95% confidence interval, 1.11-2.05), but the trend was statistically nonsignificant.

The association was significant for CD (HR, 2.05; 95% CI, 1.22,3.46) but not for UC (HR, 1.31; 95% CI, 0.89-1.92). The positive association between sugar-sweetened drinks and risk of CD, but not UC, was in line with previous studies showing that dietary patterns were more associated with CD risk, the authors noted.

They also highlighted that there was no positive link between artificially sweetened beverages, natural juices, or total sugar intake and IBD risk. They noted that the inflammatory role of artificial sweeteners is still being debated.

Additionally, the effect of natural sugar in juices may be counteracted by fiber and bioactive compounds in the juices, the authors wrote.

A limitation of the study is that at baseline, all participants in the UK Biobank were older than 40 years, so the researchers could not examine any links with younger-onset IBD.

Additionally, the self-reported questionnaires are subject to recall bias, though the survey has been validated.
 

Study adds to previous evidence

Hasan Zaki, PhD, an assistant professor with the department of pathology at University of Texas Southwestern Medical Center, Dallas, said in an interview that the size of this population-based study adds evidence that simple sugar can increase the risk for IBD. Dr. Zaki studies the relationship of inflammatory disorders and diet and was not involved in the study.

“This study is very strong evidence of the association between high sugar and IBD,” he said. He noted that more studies are needed because there are few studies in this area and results have varied.

His lab conducted work on the subject previously in mice. In a 2020 study, they found that a high-sugar diet helped promote IBD development and gut microbiota dysfunction.

Dr. Zaki pointed out that, among people in the United Kingdom and those in the United States, diets, demographics, and IBD incidence are similar, a fact that may make the findings more generalizable.

However, studies comparing the categories of sweetened drinks should be conducted in a U.S. population to assess the results in a diverse group to see whether ethnicity plays a role, because almost all of the people in the UK group were White, he said.

Also important, Dr. Zaki said, will be follow-up studies of the link between sweet drinks and IBD in U.S. children, among whom consumption is particularly high and the IBD incidence is rising. One study showed the prevalence increased 133% from 2007 to 2016.

The results of this study should help gastroenterologists counsel patients on an ideal diet to avoid IBD or reduce IBD severity, he said.

The study was supported by the National Natural Science Foundation of China and Key Project of Research and Development Plan of Hunan Province. The study authors and Dr. Zaki report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Drinks sweetened with sugar – but not natural juices or drinks sweetened artificially – were linked to a higher risk of inflammatory bowel disease (IBD) in people who drank more than one a day in a study of more than 120,000 people.

IBD has previously been linked with high consumption of sugar, but population-based evidence has been inconclusive, and natural juices have not been studied, write lead author Tian Fu, with the department of gastroenterology, the Third Xiangya Hospital of Central South University in Changsha, China, and colleagues.

Their study compared the associations of sugar-sweetened drinks, artificially sweetened beverages, and natural juices (including pure fruit or vegetable juices) with IBD risk.

“As one of the major sources of free sugar, beverages have been related to inflammation-related health outcomes but received less attention in the field of IBD,” the authors wrote.

“Our findings, if proven causal, suggest reduced consumption of sugar-sweetened beverages as a strategy for prevention of IBD, especially Crohn’s disease (CD), but further studies are needed to confirm these findings and explore the underlying mechanism,” they write.

The study was published online in Alimentary Pharmacology and Therapeutics.
 

Link significant for Crohn’s disease but not ulcerative colitis

The researchers used data from 121,490 participants in the UK Biobank who did not have IBD at trial recruitment in 2006-2010. The average age of the participants was 56 years, and almost all (96.9%) were White. The researchers studied their intake of beverages with 24-hour diet recalls from 2009 to 2012.

Participants were sorted into three groups according to the consumption of each beverage: 0 unit (glasses, cans, or 250 mL/cartons) per day (reference group), 0-1 unit per day, and more than 1 unit per day.

While most (66.3%) did not drink any sugar-sweetened beverages, participants who reported drinking more than 1 unit per day were more likely to have a higher body mass index and consume higher amounts of total energy and sugar.

During an average follow-up of about 10 years, the investigators documented 510 incident IBD cases: 143 cases of CD and 367 cases of ulcerative colitis (UC).

Compared to people who did not drink sugar-sweetened beverages, those who drank at least 1 unit per day had a significantly higher IBD risk (hazard ratio, 1.51; 95% confidence interval, 1.11-2.05), but the trend was statistically nonsignificant.

The association was significant for CD (HR, 2.05; 95% CI, 1.22,3.46) but not for UC (HR, 1.31; 95% CI, 0.89-1.92). The positive association between sugar-sweetened drinks and risk of CD, but not UC, was in line with previous studies showing that dietary patterns were more associated with CD risk, the authors noted.

They also highlighted that there was no positive link between artificially sweetened beverages, natural juices, or total sugar intake and IBD risk. They noted that the inflammatory role of artificial sweeteners is still being debated.

Additionally, the effect of natural sugar in juices may be counteracted by fiber and bioactive compounds in the juices, the authors wrote.

A limitation of the study is that at baseline, all participants in the UK Biobank were older than 40 years, so the researchers could not examine any links with younger-onset IBD.

Additionally, the self-reported questionnaires are subject to recall bias, though the survey has been validated.
 

Study adds to previous evidence

Hasan Zaki, PhD, an assistant professor with the department of pathology at University of Texas Southwestern Medical Center, Dallas, said in an interview that the size of this population-based study adds evidence that simple sugar can increase the risk for IBD. Dr. Zaki studies the relationship of inflammatory disorders and diet and was not involved in the study.

“This study is very strong evidence of the association between high sugar and IBD,” he said. He noted that more studies are needed because there are few studies in this area and results have varied.

His lab conducted work on the subject previously in mice. In a 2020 study, they found that a high-sugar diet helped promote IBD development and gut microbiota dysfunction.

Dr. Zaki pointed out that, among people in the United Kingdom and those in the United States, diets, demographics, and IBD incidence are similar, a fact that may make the findings more generalizable.

However, studies comparing the categories of sweetened drinks should be conducted in a U.S. population to assess the results in a diverse group to see whether ethnicity plays a role, because almost all of the people in the UK group were White, he said.

Also important, Dr. Zaki said, will be follow-up studies of the link between sweet drinks and IBD in U.S. children, among whom consumption is particularly high and the IBD incidence is rising. One study showed the prevalence increased 133% from 2007 to 2016.

The results of this study should help gastroenterologists counsel patients on an ideal diet to avoid IBD or reduce IBD severity, he said.

The study was supported by the National Natural Science Foundation of China and Key Project of Research and Development Plan of Hunan Province. The study authors and Dr. Zaki report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Susan Snead used to live in an apartment complex for older adults. The complex had a nice dayroom, and neighbors would knock on her door every now and then to check in.

But despite not being lonely, Ms. Snead, 89, did live alone in downtown Charleston, S.C. Eventually, that became dangerous.

“I fell a few times,” she says. “I had to call somebody to come and get me up.”

Sometimes help would come from the apartment complex’s office. Sometimes it came with a police escort.

Over time, needing to make those calls became a burden. Making and keeping appointments with her doctor, something she had to do regularly, as she has diabetes, got harder, too.

“It kind of wore me out,” she says. “Like you’re going up a hill.”

As she was beginning to accept she could no longer live alone, Ms. Snead, an Air Force veteran, learned about a program run by the Department of Veterans Affairs called Medical Foster Home.

Medical foster homes are privately owned homes in which a licensed caregiver lives with and supervises residents around the clock. Caregivers help aging veterans with activities of daily living like bathing, cooking, making and getting to appointments, getting dressed, and taking daily medication.

Caregivers can take care of up to three residents in their home at a time. While most residents are veterans, caregivers sometimes care for non-veteran residents, such as a veteran’s spouse or a caregiver’s family member.

Veterans typically pay about $1,500 to $3,000 out-of-pocket per month for the service, depending on location.

According to the VA, the concept of medical foster homes has been around since 1999, when VA hospitals across the country began reaching out to people willing to provide live-in care for veterans. The option is led by local VA hospitals, which approve caregivers and provide administrative services. There are now 517 medical foster homes, the VA says.

Much like other residential care facilities, medical foster homes get regular inspections for safety, nutrition, and more.

In 2019, Ms. Snead signed up for the program. She expected to be cared for, but she found a sense of family with her caregiver, Wilhelmina Brown, and another veteran in the home.

Ms. Brown started taking care of people – but not necessarily veterans – in 1997 when her grandmother was unable to care for herself, she says.

“My grandmama carried me to church every Sunday, she carried me to the beach – everywhere she went, she took me with her,” Ms. Brown says. As her grandmother got older, “I said, ‘I’m going to take care of her in my home.’ ”

Caring for others must come from the heart, Ms. Brown says.

She cooks her residents’ meals three times a day with dietary restrictions in mind, washes their dishes, does their laundry, remembers birthdays, and plans little parties.

“That’s my family,” Ms. Brown says.

In 2020, the COVID-19 pandemic upended the world – but at the same time, it highlighted the advantages of the medical foster home model.

Home-based primary care keeps veterans out of nursing homes – something that became particularly important as COVID-19 hit nursing homes and long-term care facilities.

Caregivers in the system were also able to help veterans, often living in rural areas, pivot and adapt to telehealth during a time of crisis.

One study, published in the journal Geriatrics, set out to identify how medical foster homes were able to deliver safe, effective health care during the early stages of the pandemic.

Researchers interviewed 37 VA care providers at 16 rural medical foster home programs across the country. The interviews took place between December 2020 and February 2021. They found medical foster home caregivers, coordinators, and health care providers communicated to move office visits to the home, helped veterans navigate telehealth, advocated to get veterans vaccinated in-home, and relied on each other to fight social isolation.

Caregivers also adapted quickly to telehealth, according to Leah Haverhals, PhD, a health research scientist and communications director for the Seattle-Denver Center of Innovation for Veteran Centered and Value Driven Care, who led the study.

Most veterans in the foster home program are older and find new technology difficult to use.

Caregivers, coordinators, and health care providers were largely new to the technology, too.

While the study found that most veterans and caregivers preferred in-person care, they were able to work together to make the best of telehealth.

“That speaks to the nature of the care being given, being able to pivot in a crisis like that,” Dr. Haverhals says.

If caregivers didn’t already have computers or telehealth-compatible devices, the VA provided iPads that would connect to the internet using cellular signals. According to the study, this helped to overcome connectivity issues that may have caused problems in rural areas.

Ms. Snead says Ms. Brown helped a lot with her telehealth calls.

“If we had to do things over the phone or with video, she was able to set that up to work with the person on the other end. She knows a lot about that stuff – about computers and things like that,” Ms. Snead says, adding that she hadn’t worked with computers since retirement in 1998.

Telehealth helped health care providers identify infections and quickly prescribe antibiotics to veterans in rural areas and provide other care that was more safely delivered in private homes.

“The findings from our study highlighted that when working together for the common goal of keeping vulnerable populations like veterans in MFHs [medical foster homes] safe during times of crisis, adaptation and collaboration facilitated the ongoing provision of high-quality care,” Dr. Haverhals’s group wrote. “Such collaboration has been shown to be critical in recent research in the United States on supporting older adults during the pandemic.”

Cari Levy, MD, PhD, a professor at the University of Colorado at Denver, Aurora, and a co-author of the study, specializes in palliative and telenursing home care for the VA.

Dr. Levy, who has worked for the VA for about 20 years, says how medical foster homes provided care during the pandemic carries lessons for civilian clinics. One of the most important lessons, she says, is that medical professionals will need to provide more care where people are, especially in populations that are too sick to get to the clinic.

“For years, there was all this hope that telehealth would expand,” but it took a pandemic to authorize approval from federal agencies to explode, she says. “I shudder to think what would have happened if we didn’t have telehealth. Fortunately, it was the right time to be able to flip a switch.”

Crisis aside, Dr. Levy says her dream would be for health care providers to do more home-based care. The model allows people to preserve the relational aspects of medicine, which can counteract a lot of the moral injury and burnout in the field, she says, adding:

“I see this as the kind of medicine many people intended to do when they got into medicine.”

A version of this article first appeared on WebMD.com.

Susan Snead used to live in an apartment complex for older adults. The complex had a nice dayroom, and neighbors would knock on her door every now and then to check in.

But despite not being lonely, Ms. Snead, 89, did live alone in downtown Charleston, S.C. Eventually, that became dangerous.

“I fell a few times,” she says. “I had to call somebody to come and get me up.”

Sometimes help would come from the apartment complex’s office. Sometimes it came with a police escort.

Over time, needing to make those calls became a burden. Making and keeping appointments with her doctor, something she had to do regularly, as she has diabetes, got harder, too.

“It kind of wore me out,” she says. “Like you’re going up a hill.”

As she was beginning to accept she could no longer live alone, Ms. Snead, an Air Force veteran, learned about a program run by the Department of Veterans Affairs called Medical Foster Home.

Medical foster homes are privately owned homes in which a licensed caregiver lives with and supervises residents around the clock. Caregivers help aging veterans with activities of daily living like bathing, cooking, making and getting to appointments, getting dressed, and taking daily medication.

Caregivers can take care of up to three residents in their home at a time. While most residents are veterans, caregivers sometimes care for non-veteran residents, such as a veteran’s spouse or a caregiver’s family member.

Veterans typically pay about $1,500 to $3,000 out-of-pocket per month for the service, depending on location.

According to the VA, the concept of medical foster homes has been around since 1999, when VA hospitals across the country began reaching out to people willing to provide live-in care for veterans. The option is led by local VA hospitals, which approve caregivers and provide administrative services. There are now 517 medical foster homes, the VA says.

Much like other residential care facilities, medical foster homes get regular inspections for safety, nutrition, and more.

In 2019, Ms. Snead signed up for the program. She expected to be cared for, but she found a sense of family with her caregiver, Wilhelmina Brown, and another veteran in the home.

Ms. Brown started taking care of people – but not necessarily veterans – in 1997 when her grandmother was unable to care for herself, she says.

“My grandmama carried me to church every Sunday, she carried me to the beach – everywhere she went, she took me with her,” Ms. Brown says. As her grandmother got older, “I said, ‘I’m going to take care of her in my home.’ ”

Caring for others must come from the heart, Ms. Brown says.

She cooks her residents’ meals three times a day with dietary restrictions in mind, washes their dishes, does their laundry, remembers birthdays, and plans little parties.

“That’s my family,” Ms. Brown says.

In 2020, the COVID-19 pandemic upended the world – but at the same time, it highlighted the advantages of the medical foster home model.

Home-based primary care keeps veterans out of nursing homes – something that became particularly important as COVID-19 hit nursing homes and long-term care facilities.

Caregivers in the system were also able to help veterans, often living in rural areas, pivot and adapt to telehealth during a time of crisis.

One study, published in the journal Geriatrics, set out to identify how medical foster homes were able to deliver safe, effective health care during the early stages of the pandemic.

Researchers interviewed 37 VA care providers at 16 rural medical foster home programs across the country. The interviews took place between December 2020 and February 2021. They found medical foster home caregivers, coordinators, and health care providers communicated to move office visits to the home, helped veterans navigate telehealth, advocated to get veterans vaccinated in-home, and relied on each other to fight social isolation.

Caregivers also adapted quickly to telehealth, according to Leah Haverhals, PhD, a health research scientist and communications director for the Seattle-Denver Center of Innovation for Veteran Centered and Value Driven Care, who led the study.

Most veterans in the foster home program are older and find new technology difficult to use.

Caregivers, coordinators, and health care providers were largely new to the technology, too.

While the study found that most veterans and caregivers preferred in-person care, they were able to work together to make the best of telehealth.

“That speaks to the nature of the care being given, being able to pivot in a crisis like that,” Dr. Haverhals says.

If caregivers didn’t already have computers or telehealth-compatible devices, the VA provided iPads that would connect to the internet using cellular signals. According to the study, this helped to overcome connectivity issues that may have caused problems in rural areas.

Ms. Snead says Ms. Brown helped a lot with her telehealth calls.

“If we had to do things over the phone or with video, she was able to set that up to work with the person on the other end. She knows a lot about that stuff – about computers and things like that,” Ms. Snead says, adding that she hadn’t worked with computers since retirement in 1998.

Telehealth helped health care providers identify infections and quickly prescribe antibiotics to veterans in rural areas and provide other care that was more safely delivered in private homes.

“The findings from our study highlighted that when working together for the common goal of keeping vulnerable populations like veterans in MFHs [medical foster homes] safe during times of crisis, adaptation and collaboration facilitated the ongoing provision of high-quality care,” Dr. Haverhals’s group wrote. “Such collaboration has been shown to be critical in recent research in the United States on supporting older adults during the pandemic.”

Cari Levy, MD, PhD, a professor at the University of Colorado at Denver, Aurora, and a co-author of the study, specializes in palliative and telenursing home care for the VA.

Dr. Levy, who has worked for the VA for about 20 years, says how medical foster homes provided care during the pandemic carries lessons for civilian clinics. One of the most important lessons, she says, is that medical professionals will need to provide more care where people are, especially in populations that are too sick to get to the clinic.

“For years, there was all this hope that telehealth would expand,” but it took a pandemic to authorize approval from federal agencies to explode, she says. “I shudder to think what would have happened if we didn’t have telehealth. Fortunately, it was the right time to be able to flip a switch.”

Crisis aside, Dr. Levy says her dream would be for health care providers to do more home-based care. The model allows people to preserve the relational aspects of medicine, which can counteract a lot of the moral injury and burnout in the field, she says, adding:

“I see this as the kind of medicine many people intended to do when they got into medicine.”

A version of this article first appeared on WebMD.com.

Susan Snead used to live in an apartment complex for older adults. The complex had a nice dayroom, and neighbors would knock on her door every now and then to check in.

But despite not being lonely, Ms. Snead, 89, did live alone in downtown Charleston, S.C. Eventually, that became dangerous.

“I fell a few times,” she says. “I had to call somebody to come and get me up.”

Sometimes help would come from the apartment complex’s office. Sometimes it came with a police escort.

Over time, needing to make those calls became a burden. Making and keeping appointments with her doctor, something she had to do regularly, as she has diabetes, got harder, too.

“It kind of wore me out,” she says. “Like you’re going up a hill.”

As she was beginning to accept she could no longer live alone, Ms. Snead, an Air Force veteran, learned about a program run by the Department of Veterans Affairs called Medical Foster Home.

Medical foster homes are privately owned homes in which a licensed caregiver lives with and supervises residents around the clock. Caregivers help aging veterans with activities of daily living like bathing, cooking, making and getting to appointments, getting dressed, and taking daily medication.

Caregivers can take care of up to three residents in their home at a time. While most residents are veterans, caregivers sometimes care for non-veteran residents, such as a veteran’s spouse or a caregiver’s family member.

Veterans typically pay about $1,500 to $3,000 out-of-pocket per month for the service, depending on location.

According to the VA, the concept of medical foster homes has been around since 1999, when VA hospitals across the country began reaching out to people willing to provide live-in care for veterans. The option is led by local VA hospitals, which approve caregivers and provide administrative services. There are now 517 medical foster homes, the VA says.

Much like other residential care facilities, medical foster homes get regular inspections for safety, nutrition, and more.

In 2019, Ms. Snead signed up for the program. She expected to be cared for, but she found a sense of family with her caregiver, Wilhelmina Brown, and another veteran in the home.

Ms. Brown started taking care of people – but not necessarily veterans – in 1997 when her grandmother was unable to care for herself, she says.

“My grandmama carried me to church every Sunday, she carried me to the beach – everywhere she went, she took me with her,” Ms. Brown says. As her grandmother got older, “I said, ‘I’m going to take care of her in my home.’ ”

Caring for others must come from the heart, Ms. Brown says.

She cooks her residents’ meals three times a day with dietary restrictions in mind, washes their dishes, does their laundry, remembers birthdays, and plans little parties.

“That’s my family,” Ms. Brown says.

In 2020, the COVID-19 pandemic upended the world – but at the same time, it highlighted the advantages of the medical foster home model.

Home-based primary care keeps veterans out of nursing homes – something that became particularly important as COVID-19 hit nursing homes and long-term care facilities.

Caregivers in the system were also able to help veterans, often living in rural areas, pivot and adapt to telehealth during a time of crisis.

One study, published in the journal Geriatrics, set out to identify how medical foster homes were able to deliver safe, effective health care during the early stages of the pandemic.

Researchers interviewed 37 VA care providers at 16 rural medical foster home programs across the country. The interviews took place between December 2020 and February 2021. They found medical foster home caregivers, coordinators, and health care providers communicated to move office visits to the home, helped veterans navigate telehealth, advocated to get veterans vaccinated in-home, and relied on each other to fight social isolation.

Caregivers also adapted quickly to telehealth, according to Leah Haverhals, PhD, a health research scientist and communications director for the Seattle-Denver Center of Innovation for Veteran Centered and Value Driven Care, who led the study.

Most veterans in the foster home program are older and find new technology difficult to use.

Caregivers, coordinators, and health care providers were largely new to the technology, too.

While the study found that most veterans and caregivers preferred in-person care, they were able to work together to make the best of telehealth.

“That speaks to the nature of the care being given, being able to pivot in a crisis like that,” Dr. Haverhals says.

If caregivers didn’t already have computers or telehealth-compatible devices, the VA provided iPads that would connect to the internet using cellular signals. According to the study, this helped to overcome connectivity issues that may have caused problems in rural areas.

Ms. Snead says Ms. Brown helped a lot with her telehealth calls.

“If we had to do things over the phone or with video, she was able to set that up to work with the person on the other end. She knows a lot about that stuff – about computers and things like that,” Ms. Snead says, adding that she hadn’t worked with computers since retirement in 1998.

Telehealth helped health care providers identify infections and quickly prescribe antibiotics to veterans in rural areas and provide other care that was more safely delivered in private homes.

“The findings from our study highlighted that when working together for the common goal of keeping vulnerable populations like veterans in MFHs [medical foster homes] safe during times of crisis, adaptation and collaboration facilitated the ongoing provision of high-quality care,” Dr. Haverhals’s group wrote. “Such collaboration has been shown to be critical in recent research in the United States on supporting older adults during the pandemic.”

Cari Levy, MD, PhD, a professor at the University of Colorado at Denver, Aurora, and a co-author of the study, specializes in palliative and telenursing home care for the VA.

Dr. Levy, who has worked for the VA for about 20 years, says how medical foster homes provided care during the pandemic carries lessons for civilian clinics. One of the most important lessons, she says, is that medical professionals will need to provide more care where people are, especially in populations that are too sick to get to the clinic.

“For years, there was all this hope that telehealth would expand,” but it took a pandemic to authorize approval from federal agencies to explode, she says. “I shudder to think what would have happened if we didn’t have telehealth. Fortunately, it was the right time to be able to flip a switch.”

Crisis aside, Dr. Levy says her dream would be for health care providers to do more home-based care. The model allows people to preserve the relational aspects of medicine, which can counteract a lot of the moral injury and burnout in the field, she says, adding:

“I see this as the kind of medicine many people intended to do when they got into medicine.”

A version of this article first appeared on WebMD.com.

A new study suggests that going beyond current guidance on moderate and vigorous physical activity levels may add years to one’s life.

Americans are advised to do a minimum of 150-300 minutes a week of moderate exercise or 75-150 minutes a week of vigorous exercise, or an equivalent combination of both, according to U.S. Department of Health and Human Services Physical Activity Guidelines.

Results from more than 100,000 U.S. adults followed for 30 years showed that individuals who performed double the currently recommended range of either moderate or vigorous physical activity weekly had the lowest long-term risk of mortality.

Adults who reported completing four times the minimum recommended activity levels saw no clear incremental mortality benefit but also no harm, according to the study, published in the journal Circulation.

“I think we’re worried more about the lower end and people that are not even doing the minimum, but this should be reassuring to people who like to do a lot of exercise,” senior author Edward Giovannucci, MD, ScD, with the Harvard T.H. Chan School of Public Health, Boston, told this news organization.

Some studies have suggested that long-term, high-intensity exercise (e.g., marathons, triathlons, and long-distance cycling) may be associated with increased risks of atrial fibrillation, coronary artery calcification, and sudden cardiac death.

A recent analysis from the Copenhagen City Heart Study showed a U-shaped association between long-term all-cause mortality and 0 to 2.5 hours and more than 10 hours of weekly, leisure-time sports activities.

Most studies suggesting harm, however, have used only one measurement of physical activity capturing a mix of people who chronically exercise at high levels and those who do it sporadically, which possibly can be harmful, Dr. Giovannucci said. “We were better able to look at consistent long-term activity and saw there was no harm.”

The study included 116,221 participants in the Nurses’ Health Study and the Health Professionals Follow-up Study between 1988 and 2018, who completed up to 15 (median, 11) questionnaires on their health and leisure-time physical activity that were updated every 2 years.

Most were White (96%), 63% were female, and the average age and body mass index over follow-up was 66 years and 26 kg/m². During 30 years of follow-up, there were 47,596 deaths.
 

‘Any effort is worthwhile’

The analysis found that individuals who met the guideline for long-term vigorous physical activity (75-150 min/week) cut their adjusted risk of death from cardiovascular disease (CVD) by a whopping 31%, from non-CVD causes by 15%, and all-causes by 19%, compared with those with no long-term vigorous activity.

Those completing two to four times the recommended minimum (150-299 min/week) had a 27%-33% lower risk of CVD mortality, 19% lower risk of non-CVD mortality, and 21%-23% lower risk of all-cause mortality.

Higher levels did not appear to further lower mortality risk. For example, 300-374 min/week of vigorous physical activity was associated with a 32% lower risk of CVD death, 18% lower risk of non-CVD death, and 22% lower risk of dying from any cause.

The analysis also found that individuals who met the guidelines for moderate physical activity had lower CVD, non-CVD, and all-cause mortality risks whether they were active 150-244 min/week (22%, 19%, and 20%, respectively) or 225-299 min/week (21%, 25%, and 20%, respectively), compared with those with almost no long-term moderate activity.

Those fitting in two to four times the recommended minimum (300-599 min/week) had a 28%-38% lower risk of CVD mortality, 25%-27% lower risk of non-CVD mortality, and 26%-31% lower risk of all-cause mortality.

The mortality benefit appeared to plateau, with 600 min/week of moderate physical activity showing associations similar to 300-599 min/week.

“The sweet spot seems to be two to four times the recommended levels but for people who are sedentary, I think one of the key messages that I give my patients is that any effort is worthwhile; that any physical activity, even less than the recommended, has some mortality reduction,” Erin Michos, MD, MHS, associate director of preventive cardiology at Johns Hopkins University, Baltimore, said in an interview.

Indeed, individuals who reported doing just 20-74 minutes of moderate exercise per week had a 19% lower risk of dying from any cause and a 13% lower risk of dying from CVD compared with those doing less.

Current American Heart Association (AHA) recommendations are for at least 150 minutes per week of moderate-intensity aerobic exercise or 75 minutes per week of vigorous aerobic exercise, or a combination of both.

“This suggests that even more is probably better, in the range of two to four times that, so maybe we should move our targets a little bit higher, which is kind of what the Department of Health and Human Services has already done,” said Dr. Michos, who was not involved in the study.

Former AHA president Donna K. Arnett, PhD, who was not involved in the study, said in a statement that “we’ve known for a long time that moderate or intense levels of physical exercise can reduce a person’s risk of both atherosclerotic cardiovascular disease and mortality.

“We have also seen that getting more than 300 minutes of moderate-intensity aerobic physical activity or more than 150 minutes of vigorous-intensity aerobic physical exercise each week may reduce a person’s risk of atherosclerotic cardiovascular disease even further, so it makes sense that getting those extra minutes of exercise may also decrease mortality,” she added.
 

Mix and match

Dr. Giovannucci noted that the joint effects of the two types of exercise on mortality have not been studied and “there are some questions, for example, about whether doing a lot of moderate activity is sufficient or can you get more benefits by doing vigorous activity also.”

Joint analyses of both exercise intensities found that additional vigorous physical activity was associated with lower mortality among participants with insufficient (less than 300 min/week) levels of moderate exercise but not among those with at least 300 min/week of moderate exercise.

“The main message is that you can get essentially all of the benefit by just doing moderate exercise,” Dr. Giovannucci said. “There’s no magic benefit of doing vigorous [exercise]. But if someone wants to do vigorous, they can get the benefit in about half the time. So if you only have 2-3 hours a week to exercise and can do, say 2 or 3 hours of running, you can get pretty much the maximum benefit.”

Sensitivity analyses showed a consistent association between long-term leisure physical activity and mortality without adjustment for body mass index/calorie intake.

“Some people think the effect of exercise is to lower your body weight or keep it down, which could be one of the benefits, but even independent of that, you get benefits even if it has no effect on your weight,” he said. “So, definitely, that’s important.”

Dr. Michos pointed out that vigorous physical activity may seem daunting for many individuals but that moderate exercise can include activities such as brisk walking, ballroom dancing, active yoga, and recreational swimming.

“The nice thing is that you can really combine or substitute both and get just as similar mortality reductions with moderate physical activity, because a lot of patients may not want to do vigorous activity,” she said. “They don’t want to get on the treadmill; that’s too intimidating or stressful.”

The study was supported by the National Institutes of Health. The authors and Dr. Michos report no relevant financial relationships.

A version of this article first appeared on Medscape.com.


A new study suggests that going beyond current guidance on moderate and vigorous physical activity levels may add years to one’s life.

Americans are advised to do a minimum of 150-300 minutes a week of moderate exercise or 75-150 minutes a week of vigorous exercise, or an equivalent combination of both, according to U.S. Department of Health and Human Services Physical Activity Guidelines.

Results from more than 100,000 U.S. adults followed for 30 years showed that individuals who performed double the currently recommended range of either moderate or vigorous physical activity weekly had the lowest long-term risk of mortality.

Adults who reported completing four times the minimum recommended activity levels saw no clear incremental mortality benefit but also no harm, according to the study, published in the journal Circulation.

“I think we’re worried more about the lower end and people that are not even doing the minimum, but this should be reassuring to people who like to do a lot of exercise,” senior author Edward Giovannucci, MD, ScD, with the Harvard T.H. Chan School of Public Health, Boston, told this news organization.

Some studies have suggested that long-term, high-intensity exercise (e.g., marathons, triathlons, and long-distance cycling) may be associated with increased risks of atrial fibrillation, coronary artery calcification, and sudden cardiac death.

A recent analysis from the Copenhagen City Heart Study showed a U-shaped association between long-term all-cause mortality and 0 to 2.5 hours and more than 10 hours of weekly, leisure-time sports activities.

Most studies suggesting harm, however, have used only one measurement of physical activity capturing a mix of people who chronically exercise at high levels and those who do it sporadically, which possibly can be harmful, Dr. Giovannucci said. “We were better able to look at consistent long-term activity and saw there was no harm.”

The study included 116,221 participants in the Nurses’ Health Study and the Health Professionals Follow-up Study between 1988 and 2018, who completed up to 15 (median, 11) questionnaires on their health and leisure-time physical activity that were updated every 2 years.

Most were White (96%), 63% were female, and the average age and body mass index over follow-up was 66 years and 26 kg/m². During 30 years of follow-up, there were 47,596 deaths.
 

‘Any effort is worthwhile’

The analysis found that individuals who met the guideline for long-term vigorous physical activity (75-150 min/week) cut their adjusted risk of death from cardiovascular disease (CVD) by a whopping 31%, from non-CVD causes by 15%, and all-causes by 19%, compared with those with no long-term vigorous activity.

Those completing two to four times the recommended minimum (150-299 min/week) had a 27%-33% lower risk of CVD mortality, 19% lower risk of non-CVD mortality, and 21%-23% lower risk of all-cause mortality.

Higher levels did not appear to further lower mortality risk. For example, 300-374 min/week of vigorous physical activity was associated with a 32% lower risk of CVD death, 18% lower risk of non-CVD death, and 22% lower risk of dying from any cause.

The analysis also found that individuals who met the guidelines for moderate physical activity had lower CVD, non-CVD, and all-cause mortality risks whether they were active 150-244 min/week (22%, 19%, and 20%, respectively) or 225-299 min/week (21%, 25%, and 20%, respectively), compared with those with almost no long-term moderate activity.

Those fitting in two to four times the recommended minimum (300-599 min/week) had a 28%-38% lower risk of CVD mortality, 25%-27% lower risk of non-CVD mortality, and 26%-31% lower risk of all-cause mortality.

The mortality benefit appeared to plateau, with 600 min/week of moderate physical activity showing associations similar to 300-599 min/week.

“The sweet spot seems to be two to four times the recommended levels but for people who are sedentary, I think one of the key messages that I give my patients is that any effort is worthwhile; that any physical activity, even less than the recommended, has some mortality reduction,” Erin Michos, MD, MHS, associate director of preventive cardiology at Johns Hopkins University, Baltimore, said in an interview.

Indeed, individuals who reported doing just 20-74 minutes of moderate exercise per week had a 19% lower risk of dying from any cause and a 13% lower risk of dying from CVD compared with those doing less.

Current American Heart Association (AHA) recommendations are for at least 150 minutes per week of moderate-intensity aerobic exercise or 75 minutes per week of vigorous aerobic exercise, or a combination of both.

“This suggests that even more is probably better, in the range of two to four times that, so maybe we should move our targets a little bit higher, which is kind of what the Department of Health and Human Services has already done,” said Dr. Michos, who was not involved in the study.

Former AHA president Donna K. Arnett, PhD, who was not involved in the study, said in a statement that “we’ve known for a long time that moderate or intense levels of physical exercise can reduce a person’s risk of both atherosclerotic cardiovascular disease and mortality.

“We have also seen that getting more than 300 minutes of moderate-intensity aerobic physical activity or more than 150 minutes of vigorous-intensity aerobic physical exercise each week may reduce a person’s risk of atherosclerotic cardiovascular disease even further, so it makes sense that getting those extra minutes of exercise may also decrease mortality,” she added.
 

Mix and match

Dr. Giovannucci noted that the joint effects of the two types of exercise on mortality have not been studied and “there are some questions, for example, about whether doing a lot of moderate activity is sufficient or can you get more benefits by doing vigorous activity also.”

Joint analyses of both exercise intensities found that additional vigorous physical activity was associated with lower mortality among participants with insufficient (less than 300 min/week) levels of moderate exercise but not among those with at least 300 min/week of moderate exercise.

“The main message is that you can get essentially all of the benefit by just doing moderate exercise,” Dr. Giovannucci said. “There’s no magic benefit of doing vigorous [exercise]. But if someone wants to do vigorous, they can get the benefit in about half the time. So if you only have 2-3 hours a week to exercise and can do, say 2 or 3 hours of running, you can get pretty much the maximum benefit.”

Sensitivity analyses showed a consistent association between long-term leisure physical activity and mortality without adjustment for body mass index/calorie intake.

“Some people think the effect of exercise is to lower your body weight or keep it down, which could be one of the benefits, but even independent of that, you get benefits even if it has no effect on your weight,” he said. “So, definitely, that’s important.”

Dr. Michos pointed out that vigorous physical activity may seem daunting for many individuals but that moderate exercise can include activities such as brisk walking, ballroom dancing, active yoga, and recreational swimming.

“The nice thing is that you can really combine or substitute both and get just as similar mortality reductions with moderate physical activity, because a lot of patients may not want to do vigorous activity,” she said. “They don’t want to get on the treadmill; that’s too intimidating or stressful.”

The study was supported by the National Institutes of Health. The authors and Dr. Michos report no relevant financial relationships.

A version of this article first appeared on Medscape.com.


A new study suggests that going beyond current guidance on moderate and vigorous physical activity levels may add years to one’s life.

Americans are advised to do a minimum of 150-300 minutes a week of moderate exercise or 75-150 minutes a week of vigorous exercise, or an equivalent combination of both, according to U.S. Department of Health and Human Services Physical Activity Guidelines.

Results from more than 100,000 U.S. adults followed for 30 years showed that individuals who performed double the currently recommended range of either moderate or vigorous physical activity weekly had the lowest long-term risk of mortality.

Adults who reported completing four times the minimum recommended activity levels saw no clear incremental mortality benefit but also no harm, according to the study, published in the journal Circulation.

“I think we’re worried more about the lower end and people that are not even doing the minimum, but this should be reassuring to people who like to do a lot of exercise,” senior author Edward Giovannucci, MD, ScD, with the Harvard T.H. Chan School of Public Health, Boston, told this news organization.

Some studies have suggested that long-term, high-intensity exercise (e.g., marathons, triathlons, and long-distance cycling) may be associated with increased risks of atrial fibrillation, coronary artery calcification, and sudden cardiac death.

A recent analysis from the Copenhagen City Heart Study showed a U-shaped association between long-term all-cause mortality and 0 to 2.5 hours and more than 10 hours of weekly, leisure-time sports activities.

Most studies suggesting harm, however, have used only one measurement of physical activity capturing a mix of people who chronically exercise at high levels and those who do it sporadically, which possibly can be harmful, Dr. Giovannucci said. “We were better able to look at consistent long-term activity and saw there was no harm.”

The study included 116,221 participants in the Nurses’ Health Study and the Health Professionals Follow-up Study between 1988 and 2018, who completed up to 15 (median, 11) questionnaires on their health and leisure-time physical activity that were updated every 2 years.

Most were White (96%), 63% were female, and the average age and body mass index over follow-up was 66 years and 26 kg/m². During 30 years of follow-up, there were 47,596 deaths.
 

‘Any effort is worthwhile’

The analysis found that individuals who met the guideline for long-term vigorous physical activity (75-150 min/week) cut their adjusted risk of death from cardiovascular disease (CVD) by a whopping 31%, from non-CVD causes by 15%, and all-causes by 19%, compared with those with no long-term vigorous activity.

Those completing two to four times the recommended minimum (150-299 min/week) had a 27%-33% lower risk of CVD mortality, 19% lower risk of non-CVD mortality, and 21%-23% lower risk of all-cause mortality.

Higher levels did not appear to further lower mortality risk. For example, 300-374 min/week of vigorous physical activity was associated with a 32% lower risk of CVD death, 18% lower risk of non-CVD death, and 22% lower risk of dying from any cause.

The analysis also found that individuals who met the guidelines for moderate physical activity had lower CVD, non-CVD, and all-cause mortality risks whether they were active 150-244 min/week (22%, 19%, and 20%, respectively) or 225-299 min/week (21%, 25%, and 20%, respectively), compared with those with almost no long-term moderate activity.

Those fitting in two to four times the recommended minimum (300-599 min/week) had a 28%-38% lower risk of CVD mortality, 25%-27% lower risk of non-CVD mortality, and 26%-31% lower risk of all-cause mortality.

The mortality benefit appeared to plateau, with 600 min/week of moderate physical activity showing associations similar to 300-599 min/week.

“The sweet spot seems to be two to four times the recommended levels but for people who are sedentary, I think one of the key messages that I give my patients is that any effort is worthwhile; that any physical activity, even less than the recommended, has some mortality reduction,” Erin Michos, MD, MHS, associate director of preventive cardiology at Johns Hopkins University, Baltimore, said in an interview.

Indeed, individuals who reported doing just 20-74 minutes of moderate exercise per week had a 19% lower risk of dying from any cause and a 13% lower risk of dying from CVD compared with those doing less.

Current American Heart Association (AHA) recommendations are for at least 150 minutes per week of moderate-intensity aerobic exercise or 75 minutes per week of vigorous aerobic exercise, or a combination of both.

“This suggests that even more is probably better, in the range of two to four times that, so maybe we should move our targets a little bit higher, which is kind of what the Department of Health and Human Services has already done,” said Dr. Michos, who was not involved in the study.

Former AHA president Donna K. Arnett, PhD, who was not involved in the study, said in a statement that “we’ve known for a long time that moderate or intense levels of physical exercise can reduce a person’s risk of both atherosclerotic cardiovascular disease and mortality.

“We have also seen that getting more than 300 minutes of moderate-intensity aerobic physical activity or more than 150 minutes of vigorous-intensity aerobic physical exercise each week may reduce a person’s risk of atherosclerotic cardiovascular disease even further, so it makes sense that getting those extra minutes of exercise may also decrease mortality,” she added.
 

Mix and match

Dr. Giovannucci noted that the joint effects of the two types of exercise on mortality have not been studied and “there are some questions, for example, about whether doing a lot of moderate activity is sufficient or can you get more benefits by doing vigorous activity also.”

Joint analyses of both exercise intensities found that additional vigorous physical activity was associated with lower mortality among participants with insufficient (less than 300 min/week) levels of moderate exercise but not among those with at least 300 min/week of moderate exercise.

“The main message is that you can get essentially all of the benefit by just doing moderate exercise,” Dr. Giovannucci said. “There’s no magic benefit of doing vigorous [exercise]. But if someone wants to do vigorous, they can get the benefit in about half the time. So if you only have 2-3 hours a week to exercise and can do, say 2 or 3 hours of running, you can get pretty much the maximum benefit.”

Sensitivity analyses showed a consistent association between long-term leisure physical activity and mortality without adjustment for body mass index/calorie intake.

“Some people think the effect of exercise is to lower your body weight or keep it down, which could be one of the benefits, but even independent of that, you get benefits even if it has no effect on your weight,” he said. “So, definitely, that’s important.”

Dr. Michos pointed out that vigorous physical activity may seem daunting for many individuals but that moderate exercise can include activities such as brisk walking, ballroom dancing, active yoga, and recreational swimming.

“The nice thing is that you can really combine or substitute both and get just as similar mortality reductions with moderate physical activity, because a lot of patients may not want to do vigorous activity,” she said. “They don’t want to get on the treadmill; that’s too intimidating or stressful.”

The study was supported by the National Institutes of Health. The authors and Dr. Michos report no relevant financial relationships.

A version of this article first appeared on Medscape.com.


“Children’s hospitals saw a more than 25% decline in injury-related emergency room visits during the first year of the pandemic.” There’s a headline that should soothe a nation starved for some good news. It was based on a study published in Pediatrics that reports on data collected in the Pediatric Health Information System between March 2020 and March 2021 using a 3-year period between 2017 and 2020 as a control. How could this not be good news? First, let’s not be too hasty in celebrating the good fortune of all those millions of children spared the pain and anxiety of an emergency department visit.

If you were an administrator of an emergency department attempting to match revenues with expenses, a 25% drop in visits may have hit your bottom line. Office-based pediatricians experienced a similar phenomenon when many parents quickly learned that they could ignore or self-manage minor illnesses and complaints.

A decrease in visits doesn’t necessarily mean that the conditions that drive the traffic flow in your facility have gone away. It may simply be that they are being managed somewhere else. However, it is equally likely that for some reason the pandemic created situations that made the usual illnesses and injuries that flood into emergency departments less likely to occur. And, here, other anecdotal evidence about weight gain and a decline in fitness point to the conclusion that when children are no longer in school, they settle into more sedentary and less injury-generating activities. Injuries from falling off the couch watching television or playing video games alone do occur but certainly with less frequency than the random collisions that are inevitable when scores of classmates are running around on the playground.

So while it may be tempting to view a decline in emergency department visits as a positive statistic, this pandemic should remind us to be careful about how we choose our metrics to measure the health of the community. A decline in injuries in the short term may be masking a more serious erosion in the health of the pediatric population over the long term. At times I worry that as a specialty we are so focused on injury prevention that we lose sight of the fact that being physically active comes with a risk. A risk that we may wish to minimize, but a risk we must accept if we want to encourage the physical activity that we know is so important in the bigger health picture. For example, emergency department visits caused by pedal cycles initially rose 60%, eventually settling into the 25%-30% range leading one to suspect there was a learning or relearning curve.

However, while visits for minor injuries declined 25%, those associated with firearms rose initially 22%, and then 42%, and finally over 35%. These numbers combined with significant increases in visits from suffocation, nonpedal transportation, and suicide intent make it clear that, for most children, being in school is significantly less dangerous than staying at home.

As the pandemic continues to tumble on and we are presented with future questions about whether to keep schools open or closed, I hope the results of this study and others will help school officials and their advisers step back and look beyond the simple metric of case numbers and appreciate that there are benefits to being in school that go far beyond what can be learned in class.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

“Children’s hospitals saw a more than 25% decline in injury-related emergency room visits during the first year of the pandemic.” There’s a headline that should soothe a nation starved for some good news. It was based on a study published in Pediatrics that reports on data collected in the Pediatric Health Information System between March 2020 and March 2021 using a 3-year period between 2017 and 2020 as a control. How could this not be good news? First, let’s not be too hasty in celebrating the good fortune of all those millions of children spared the pain and anxiety of an emergency department visit.

If you were an administrator of an emergency department attempting to match revenues with expenses, a 25% drop in visits may have hit your bottom line. Office-based pediatricians experienced a similar phenomenon when many parents quickly learned that they could ignore or self-manage minor illnesses and complaints.

A decrease in visits doesn’t necessarily mean that the conditions that drive the traffic flow in your facility have gone away. It may simply be that they are being managed somewhere else. However, it is equally likely that for some reason the pandemic created situations that made the usual illnesses and injuries that flood into emergency departments less likely to occur. And, here, other anecdotal evidence about weight gain and a decline in fitness point to the conclusion that when children are no longer in school, they settle into more sedentary and less injury-generating activities. Injuries from falling off the couch watching television or playing video games alone do occur but certainly with less frequency than the random collisions that are inevitable when scores of classmates are running around on the playground.

So while it may be tempting to view a decline in emergency department visits as a positive statistic, this pandemic should remind us to be careful about how we choose our metrics to measure the health of the community. A decline in injuries in the short term may be masking a more serious erosion in the health of the pediatric population over the long term. At times I worry that as a specialty we are so focused on injury prevention that we lose sight of the fact that being physically active comes with a risk. A risk that we may wish to minimize, but a risk we must accept if we want to encourage the physical activity that we know is so important in the bigger health picture. For example, emergency department visits caused by pedal cycles initially rose 60%, eventually settling into the 25%-30% range leading one to suspect there was a learning or relearning curve.

However, while visits for minor injuries declined 25%, those associated with firearms rose initially 22%, and then 42%, and finally over 35%. These numbers combined with significant increases in visits from suffocation, nonpedal transportation, and suicide intent make it clear that, for most children, being in school is significantly less dangerous than staying at home.

As the pandemic continues to tumble on and we are presented with future questions about whether to keep schools open or closed, I hope the results of this study and others will help school officials and their advisers step back and look beyond the simple metric of case numbers and appreciate that there are benefits to being in school that go far beyond what can be learned in class.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

“Children’s hospitals saw a more than 25% decline in injury-related emergency room visits during the first year of the pandemic.” There’s a headline that should soothe a nation starved for some good news. It was based on a study published in Pediatrics that reports on data collected in the Pediatric Health Information System between March 2020 and March 2021 using a 3-year period between 2017 and 2020 as a control. How could this not be good news? First, let’s not be too hasty in celebrating the good fortune of all those millions of children spared the pain and anxiety of an emergency department visit.

If you were an administrator of an emergency department attempting to match revenues with expenses, a 25% drop in visits may have hit your bottom line. Office-based pediatricians experienced a similar phenomenon when many parents quickly learned that they could ignore or self-manage minor illnesses and complaints.

A decrease in visits doesn’t necessarily mean that the conditions that drive the traffic flow in your facility have gone away. It may simply be that they are being managed somewhere else. However, it is equally likely that for some reason the pandemic created situations that made the usual illnesses and injuries that flood into emergency departments less likely to occur. And, here, other anecdotal evidence about weight gain and a decline in fitness point to the conclusion that when children are no longer in school, they settle into more sedentary and less injury-generating activities. Injuries from falling off the couch watching television or playing video games alone do occur but certainly with less frequency than the random collisions that are inevitable when scores of classmates are running around on the playground.

So while it may be tempting to view a decline in emergency department visits as a positive statistic, this pandemic should remind us to be careful about how we choose our metrics to measure the health of the community. A decline in injuries in the short term may be masking a more serious erosion in the health of the pediatric population over the long term. At times I worry that as a specialty we are so focused on injury prevention that we lose sight of the fact that being physically active comes with a risk. A risk that we may wish to minimize, but a risk we must accept if we want to encourage the physical activity that we know is so important in the bigger health picture. For example, emergency department visits caused by pedal cycles initially rose 60%, eventually settling into the 25%-30% range leading one to suspect there was a learning or relearning curve.

However, while visits for minor injuries declined 25%, those associated with firearms rose initially 22%, and then 42%, and finally over 35%. These numbers combined with significant increases in visits from suffocation, nonpedal transportation, and suicide intent make it clear that, for most children, being in school is significantly less dangerous than staying at home.

As the pandemic continues to tumble on and we are presented with future questions about whether to keep schools open or closed, I hope the results of this study and others will help school officials and their advisers step back and look beyond the simple metric of case numbers and appreciate that there are benefits to being in school that go far beyond what can be learned in class.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].